Exhibit 99.1

Albireo Reports Third Quarter 2017 Financial Results

 

 

Executing towards planned A4250 Phase 3 PFIC trial —

 

 

Decision on potential approval of elobixibat in Japan expected in the first half of 2018 —

 

 

BOSTON — November 14, 2017

— Albireo Pharma, Inc. (NASDAQ:ALBO), a clinical-stage orphan pediatric liver disease company developing novel bile acid modulators, today reported its financial results for the third quarter and nine months ended September 30, 2017 and provided a business update.

 

“In the third quarter, we took key steps toward our goal of bringing A4250 as a non-surgical treatment option to children suffering from progressive familial intrahepatic cholestasis (PFIC), a devastating and rare genetic liver disease for which there is no approved drug treatment,” said Ron Cooper, President and Chief Executive Officer of Albireo. “In particular, as we are developing A4250 to treat a pediatric population, we were delighted that the European Medicines Agency’s Paediatric Committee, which is responsible for activities on potential medicines for pediatric populations and supporting their EU development, agreed to our pediatric investigation plan (PIP) for A4250 in PFIC. Our planned Phase 3 clinical trial of A4250 in patients with PFIC is a key component of the agreed PIP, and we look forward to getting that study underway.”

 

Albireo reported a net loss of $6.5 million for the third quarter of 2017 compared with a net loss of $4.0 million for the third quarter of 2016. For the nine months ended September 30, 2017, Albireo reported a net loss of $19.4 million compared with a net loss of $5.1 million for the corresponding 2016 period. As of September 30, 2017, cash and cash equivalents totaled $57.1 million. Based on current operating plans, Albireo expects its current cash resources will be sufficient to meet its operating requirements through at least the end of 2019, assuming receipt of a contingent milestone payment from licensee EA Pharma in 2018.

 

Recent Highlights and Corporate Update

 

A4250

 

Continued to execute towards the planned initiation of a Phase 3 trial of A4250 in patients with PFIC.  Albireo submitted the study protocol and is currently addressing refinements suggested by the FDA, with no change to the key study design details previously announced. Albireo now expects to initiate the Phase 3 trial by the spring of 2018.

Final results from Albireo’s Phase 2 clinical trial of A4250 in children with cholestatic liver disease and pruritus were presented in October 2017 in a poster, recognized as a Presidential Poster of Distinction, and Special Interest Groups session at the American Association for the Study of Liver Diseases (AASLD) The Liver Meeting® 2017 in Washington, D.C., and in a poster, again recognized as a Poster of Distinction, at the 2017 Annual Meeting of the North American Society for Pediatric Gastroenterology, Hepatology and Nutrition in Las Vegas. In the study, A4250 reduced serum bile acids (sBA) and improved pruritus in most patients, particularly patients with PFIC. A4250 exhibited a favorable overall tolerability profile in the study, with all patients completing the four-week treatment period and no reports of diarrhea associated with multiple dose therapy.


The following information was filed by Albireo Pharma, Inc. (ALBO) on Tuesday, November 14, 2017 as an 8K 2.02 statement, which is an earnings press release pertaining to results of operations and financial condition. It may be helpful to assess the quality of management by comparing the information in the press release to the information in the accompanying 10-Q Quarterly Report statement of earnings and operation as management may choose to highlight particular information in the press release.

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